Aceclidine/Brimonidine

7月31日，LENZ Therapeutics宣布用于治疗老视（即老花眼）的LNZ100滴眼液（1.75%醋克利定）已获FDA批准上市。该药物已在中国申报上市。LNZ100是LENZ Therapeutics开发的一种不含防腐剂、使用频率为每日1次的醋克利定滴眼液。醋克利定可引起瞳孔暂时性收缩，从而产生显著延长视程、改善近视力和视觉质量的光学效应。与毛果芸香碱和卡巴胆碱等其他瞳孔缩小剂不同，醋克利定的作用机制是瞳孔选择性的，这意味着它可以激活虹膜括约肌，使瞳孔缩小到直径2毫米以下，而不会过度刺激睫状肌，导致近视偏移和远视力受损。因此，醋克利定不需要任何剩余的调节来改善近距离视力，从而扩大了其对晶状体失去调节能力的老年老花眼的益处。2022年4月，LENZ Therapeutics与箕星药业就在大中华区开发和商业化针对老视治疗的LNZ100和LNZ101达成独家许可协议。END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

LENZ Therapeutics on Thursday said it secured FDA approval for Vizz (aceclidine ophthalmic solution), marking the first aceclidine-based eye drop authorised to treat presbyopia in adults, with the product slated to hit the shelves in the fourth quarter.Eef Schimmelpennink, chief executive of LENZ, said the availability of Vizz — intended for once daily administration — boosts “treatment options for the 128 million adults living with blurry near vision” in the country.The approval was supported by three late-stage studies — the pivotal brimonidine-controlled CLARITY 1 and vehicle-controlled CLARITY 2 trials assessing the eye drop’s safety and efficacy with once-daily dosing over 42 days, and CLARITY 3 evaluating long-term safety over six months.Results showed that Vizz (previously known as LNZ100) met all primary and secondary near vision improvement endpoints in both pivotal studies, demonstrating rapid onset within 30 minutes and sustained efficacy lasting up to 10 hours, alongside reproducible and consistent near vision improvement. Meanwhile, Vizz was well-tolerated, with no serious treatment-related adverse events reported over 30,000+ treatment days across all three CLARITY trials.LENZ also investigated another candidate LNZ101 — a combination of aceclidine and brimonidine — which failed to show superiority to Vizz despite meeting all endpoints in CLARITY 1 and 2, prompting the company to drop the former.Nipping at Vizz’s heels is Tenpoint Therapeutics’ Visus-derived Brimochol PF, a fixed-dose combination of carbachol and brimonidine tartrate, which demonstrated upbeat findings in a pair of Phase III presbyopia studies — BRIO-I and BRIO-II. Tenpoint recently filed a marketing application with the FDA and hopes for a product launch in the first half of next year.